Cleared Traditional

K221653 - InfaTherm Disposable Infant Warming Mattress

K221653 is an FDA 510(k) clearance for InfaTherm Disposable Infant Warming Mat..., manufactured by International Biomedical. The device is a Class 1 Physical Medicine device with product code IMD cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K221653 · International Biomedical · Physical Medicine device
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Oct 2022
Decision
121d
Days
Class 1
Risk

K221653 is an FDA 510(k) clearance for the InfaTherm Disposable Infant Warming Mattress. Classified as Pack, Hot Or Cold, Disposable (product code IMD), Class I - General Controls.

Submitted by International Biomedical (Austin, US). The FDA issued a Cleared decision on October 6, 2022 after a review of 121 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5710 - the FDA physical medicine device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all International Biomedical devices

FDA 510(k) Submission Details - K221653

510(k) Number K221653 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 2022
Decision Date October 06, 2022
Days to Decision 121 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
5d slower than avg
Panel avg: 116d · This submission: 121d
Pathway characteristics
Predicate-based equivalence.

IMD Device Classification - Class 1, General Controls

Product Code IMD Pack, Hot Or Cold, Disposable
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.5710
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - IMD Pack, Hot Or Cold, Disposable

All 35
Devices cleared under the same product code (IMD) and FDA review panel - the closest regulatory comparables to K221653.
Infant Transport Mattress Warmer with Disc
K163295 · Rapid Aid Corp. · Jul 2017
NEO NEST
K112547 · Denovo Proucts, LLC · Mar 2012
EYEFEEL OPHTHALMIC WARMER
K082087 · Bio-Lipid, Inc. · Sep 2008
BENGAY (R) HEAT THERAPY, PAIN RELIEVING PATCHES/PADS (VARIOUS)
K071710 · Johnson & Johnson Consumer Products, Inc. · Aug 2007
EYEFEEL OPHTHALMIC WARMER
K021843 · Bio-Lipid, Inc. · Sep 2002
ALLEGIANCE PORTA-WARM MATTRESS
K982652 · Allegiance Healthcare Corp. · Jan 1999